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ManualsBrandsQuidel ManualsFlu/Influenza A+B TestSofia Influenza A+B FIA Test Kit
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SofiaInfluenzaA+BFIA
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Table6
PerformanceComparedtoCultureforEachSampleTypebyAgeGroupforInfluenzaB
NasalSwabs NasopharyngealSwabs NasopharyngealAspirate/Wash
Sensitivity Specificity Sensitivity Specificity Sensitivity Specificity
AllAges
89%(100/112)
(95%CI=82%‐94%)
96%(530/553)
(95%CI=94%‐97%)
90%(101/112)
(95%CI=83%‐95%)
97%(602/621)
(95%CI=95%‐98%)
88%(46/52)
(95%CI=77%‐95%)
96%(575/597)
(95%CI=94%‐98%)
<6years
90%(35/39)
(95%CI=76%‐97%)
96%(238/247)
(95%CI=93%‐98%)
87%(54/62)
(95%CI=76%‐94%)
97%(455/471)
(95%CI=95%‐98%)
87%(39/45)
(95%CI=73%‐94%)
96%(572/594)
(95%CI=94%‐98%)
6to21
years
92%(56/61)
(95%CI=82%‐97%)
95%(187/196)
(95%CI=91%‐98%)
94%(45/48)
(95%CI=83%‐98%)
98%(130/132)
(95%CI=94%‐100%)
100%(7/7)
(95%CI=60%‐100%)
100%(3/3)
(95%CI=38%‐100%)
22to59
years
73%(8/11)
(95%CI=43%‐91%)
97%(89/92)
(95%CI=90%‐99%)
100%(2/2)
(95%CI=29%‐100%)
94%(16/17)
(95%CI=71%‐100%)
N/A(0/0) N/A(0/0)
60Years
andup
100%(1/1)
(95%CI=17%‐100%)
89%(16/18)
(95%CI=66%‐98%)
N/A(0/0)
100%(1/1)
(95%CI=17%‐100%)
N/A(0/0) N/A(0/0)
ReproducibilityStudies
ThereproducibilityoftheSofiaInfluenzaA+BFIAwasevaluatedatthreedifferentlaboratories,oneofwhich
was Quidel. Two different operators at each site tested a series of coded, contrived samples, prepared in
negativeclini cal matrix,rangingfrom lownegativetomoderatepositive influenzaAand influenzaB. Testing
occurred on 5 different days spanning over approximately a 2‐w
eek period. Theinter‐laboratory agreement
(Table 7) for negative samples was 94%‐100% and 98%‐100% for positive samples. The intra ‐laboratory
agreement(Table8)forallsamplesrangedfrom98%‐99%.
Table7
SofiaInfluenzaA+BReproducibilityStudyInter‐LaboratoryAgreement
Lab
oratory
Site
Neg
(novirus)
FluA
HighNeg
(C
5
)
FluA
LowPos(C
95
)
FluA
ModPos
(C
3X
)
FluB
HighNeg
(C
5
)
FluB
LowPos
(C
95
)
FluB
ModPos
(C
3X
)
1 30/30 29/30 30/30 30/30 28/30 29/30 30/30
2 30/30 29/30 30/30 30/30 30/30 29/30 30/30
3 30/30 30/30 30/30 30/30 27/30 30/30 30/30
Total 90/90 88/90 90/90 90/90 85/90 88/90 90/90
%Overall
Agreement
with
Expected
Result
(95%CI)
100%
(95%‐100%)
98%
(92%‐100%)
100%
(95%‐100%)
100%
(95%‐100%)
94%
(87%‐98%)
98%
(92%‐100%)
100%
(95%‐100%)